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The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis.
Pre-Surgery:
Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Pre-surgery assessments (after completion of consent process and signed ICF) will be according to the routine practice.
Intra-operative:
During surgery, an assessment of the intra-operative exclusion criteria will be performed. If the subject does not meet any of the exclusion criteria, the subject will be further enrolled. Surgery will be performed according to the site standard of care (routine practice). Anastomosis will be created either using a stapler device (linear or circular), according to manufacture IFU (Instructions for use) or hand suture according to surgeon best practice technique. Once anastomosis has been created, surgeon will verify the anastomosis and mucosal donuts integrity.
Device (Seal-G) application on anastomotic site
Post-operative follow-up: Follow-up evaluations will be performed daily while hospitalized. There will be one postoperative follow up at one month - clinic visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seal-G | Experimental | A surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seal-G | Device | Intervention: Device: Seal-G Seal-G is applied adjunctively to cover standard closure techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of device related complications | Postoperative to end of follow up (30±7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall rate of complications | Postoperative to end of follow up (30±7 days) | |
| Postoperative length of hospitalization stay | Postoperative till time for "ready to be discharged" (10±4 days) | |
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Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rina Lev, PhD | Sealantis Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | Israel | ||||
| Assaf Harofeh |
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| Duration of sealant application |
| Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes) |
| Ease of use of the device | Ease of use of the device will be rated using a Likert scale from 1 to 5 with: 1 being Very easy, 2 Easy, 3 Neutral, 4 Difficult and 5 being Very difficult. At the day of surgery (after surgery completed) the surgeon will complete a questionnaire regarding the device use and ease of application. | Intraoperative: device application |
| Tzrifin |
| Israel |
| Humanitas Research Hospital | Rozzano Milano | Italy |